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Model Number IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Osteolysis (2377)
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Event Date 02/21/2024 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
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Event Description
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On 02/21/2024, it was reported by a sales representative via sems-06493014 that a doctor is having an issue with the ar-4152ds trim-it drill pin system.The arthrex rep was just made aware of three patients who experienced osteolysis (bone loss) post-op after having hand or carpel bone wrist procedures from 2021 to 2023.No specific patient information was made available at this time.Additional information 3/12/2024 from zd: this doctor no longer works in our footprint, and i¿m unsure if he is still operating.It was his old pa who is now inquiring about it.The previous doctor's surgery was a scapholunate reconstruction, and then he would throw a couple of the ar-4152ds wires to hold stability.The pa said that there had been osteolysis in 3 of the patients anywhere from 6 months to 2 years post-surgery.No second surgeries were done because of it.
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Search Alerts/Recalls
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